Solvay unit Fournier Laboratories Ireland, has withdrawn its marketing
authorisation application for the diabetes drug and lipid lowerer combo Synordia (fenofibrate/metformin), according to the European Medicines Agency.
If approved, it would have been the first product on the market for type 2 diabetics to combine a lipid lowering drug with an oral antidiabetic in
one pill. The application for marketing authorisation was submitted to the
EMEA in July and Synordia has been under review by the agency’s Committee for Medicinal Products for Human Use.
The reason for the withdrawal is a little hazy and an EMEA statement
simply noted that the company had stated that it was due to the fact that
Solvay “is not able to respond to the request for additional information
within the allowed timeframe.”
Puck Bossert, director of pharmaceuticals communications at Solvay, told
PharmaTimes World News that, while talks with the EMEA were confidential, discussions on Synordia centred around issues of pharmocokinetics and manufacturing controls, although she added that a new application may be made at a latter stage.
As for the EMEA, it said that “the current state of the scientific assessment at the time of withdrawal will be made available in a question and answer document” to be published after the next meeting of the CHMP on December 11-14.
Major blow to Solvay
Whatever the specific reasons, the news is a major blow to Solvay, which
acquired Fournier for 1.2 billion euros last year. Fenofibrate is a big
earner for both the company and US partner Abbott Laboratories; although it is an old product, research is ongoing into a number of formulation developments and combinations to extend the lifecycle of the drug.
Solvay and Abbott announced a collaboration earlier this year with AstraZeneca to develop a product combining fenofibrate with the latter's lipid modifier Crestor (rosuvastatin) that is scheduled for submission to the US Food and Drug Administration in 2009.
However, there was better news for Solvay concerning its SLV 319 obesity
candidate. The company noted that a Phase IIb study has started,
triggering a a $25 milestone payment from partner Bristol-Myers Squibb.
